Contour Userguide

User Guide

For Use With Ascensia CONTOUR Blood Glucose Meter and Ascensia CONTOUR Test Strips

Thank you for choosing the Ascensia CONTOUR Blood Glucose Monitoring System! We are proud to be your partner in helping you manage your diabetes. Our goal is to make this the simplest, most straightforward meter you will ever use. The Ascensia CONTOUR Blood Glucose Monitoring System is intended for self-testing by people with diabetes and by healthcare professionals to monitor glucose concentrations in whole blood.

Additional Materials Ascensia C ONTOUR Test StripsUse for blood glucose or control solution testing. Supplied in a handy bottle with an easy-to-open ip-top lid. Ascensia MICROLET Lancing Device with Adjustable Endcap and clear Alternative Site Testing (AST) Endcap Use the Adjustable Endcap for testing on the ngertip. Use the clear AST Endcap for testing on the forearm or palm. BATTERIESUses two 3-volt (DL2032 or CR2032) lithium batteries. Replace when necessary. (Free Batteries For Life program. Call 1-800-348-8100.) For short simple instructions, a quick reference guide is also provided. It can be more convenient when traveling.

Your Testing Tools Your Meter Display Your Meter Features Symptoms of High or Low Blood Sugar Important Things to Know Before You Begin

2 3 4 5 6 7

Getting Ready to Test Getting the Blood Drop Fingertip Testing Alternative Site Testing (Forearm or Palm) Testing Your Blood

8 10 10 11 12

Error Codes and Symbols Control Solution Testing

15 18

Setting the Date, Time, and Sound Setting the Markers and Alarm Using the Markers and Alarm Viewing Stored Results

21 24 25 30

Changing the Batteries Caring for the System Transferring Results to a Computer Technical Information Specications Warranty Service and Supplies

32 33 34 35 36 37 39

Extras

Options

Help

Testing

Important

Table of Contents

Your Ascensia CONTOUR Meter:

Important Your Testing Tools 2

Display Up/Down Scroll Buttons Test Strip Port Your Ascensia CONTOUR Test Strip: Sample Tip: The end of the test strip where the blood is pulled in. Cocking End Release Button Lancet Holder Lancet Protective Cap Gray Electrode End: The end of the test strip that is inserted into the test strip port on the meter with the gray end facing up. Memory Button(On/Off, Memory Recall, Enter)

Your Ascensia MICROLET Lancing Device:

Adjustable Endcap Clear AST Endcap (FINGERTIPS) Need Help? Call: 1-800-348-8100 OR PALM) (FOREARM

The picture below shows all the symbols that will appear on your meter display. When the meter is off, press and continue holding the or button. All segments will be displayed and remain on while holding the button down for 10 seconds. Repeat as needed to compare your meter to the display shown below. While all characters are displayed, it is most important to verify that is fully displayed. If there is a difference, see Error Codes and Symbols (page 17). This may affect the way you see your results.Top area on the display presenting date and time. or will appear if the meter is in 12 hour setup. Displays the date format.

Indicates beeper is turned on.

. /

Indicates an alarm has been set.

AResults are displayed along with the preset units of measure. The 7 appears when viewing number of results over past 7 days. Average.

Pre-meal result marker.

Center area on the display that shows either your test result or any error codes.

Control result marker. Post-meal result marker. Indicates the meter is ready to test.

Identies a test result as unique or different.

Indicates it is too cold or too hot for your www.BayerDiabetes.com meter to test accurately.

Indicates the batteries are low and need to be changed.

Your Meter Display 3

Important

Your Meter Display

Your Meter Features Programmed: Your Ascensia CONTOUR Meter has been preset at the factory with the standard date, time, and meter features used where you live. To change these settings or use advanced meter features, such as meal markers, read through the Options section of your user guide. Easy: The Ascensia CONTOUR Blood Glucose Monitoring System is all about simplicity. You will notice its uncomplicated approach the rst time you see it. Simple things like the use of three large buttons and a clear display are sure to make this your favorite meter right from the start. Automatic: You no longer have to worry about coding your meter or marking a control test result. The Ascensia CONTOUR Meter does it automatically. It will even tell you when a test strip is under-lled. Makes Sense: You will nd features that customers just like you asked for. Practical features like a fast test time, a very small blood sample size, and a simple testing procedure (no coding required!) make the Ascensia CONTOUR Meter your meter. Convenient: Your Ascensia CONTOUR Meter takes up about as much room in your pocket or bag as your key ring. The meters small size, sleek design, and ease of use allows you to take it everywhere. You will be likely to test more often, which can mean better control of your diabetes.

Important Your Meter Features 4

Need Help? Call: 1-800-348-8100

You can better understand your test results by being aware of the symptoms of high or low blood sugar; this will also help you decide what to do if your results seem unusual. Some of the most common symptoms are:1 High blood sugar (Hyperglycemia): frequent urination excessive thirst blurred vision increased fatigue extreme hunger irritability Low blood sugar (Hypoglycemia): shakiness sweating fast heartbeat blurred vision strange behavior confusion passing out seizure

Ketones (Ketoacidosis) from untreated Hyperglycemia: shortness of breath nausea and vomiting very dry mouth

If you are experiencing any symptoms, test your blood glucose. If your test result is below 50 mg/dL or above 250 mg/dL, contact your doctor immediately. For additional information and symptoms, contact a healthcare professional or refer to the website for the American Diabetes Association: www.diabetes.org

www.BayerDiabetes.com

Symptoms of High or Low Blood Sugar 5

Important

Symptoms of High or Low Blood Sugar

Important Things to Know Your Ascensia CONTOUR Blood Glucose Meter is specic for glucose and has been referenced to plasma/serum values. Methods calibrated to plasma/serum can be 9 to 15% higher than the results of whole blood glucose assay methods. Always keep the test strips in the original bottle. Tightly close the bottle immediately after removing a test strip. The bottle is especially designed to provide a dry environment for the test strips. Extended exposure to room humidity from leaving the bottle open or not storing the test strips in the original bottle will damage your test strips. Avoid excessive milking of your nger when forming a drop of blood and test immediately after forming the blood drop. DO NOT drop blood directly on the at surface of the test strip. Your test strip is designed to easily sip the blood into the sample tip. DO NOT press the test strip against your nger. This may block the sample tip. DO NOT use a test strip that appears damaged or has been used. Test strips are for single use only. IMPORTANT NOTE: Your meter has been preset and locked to display results in mg/dL (milligrams of glucose per deciliter). Results in mg/dL will never have a decimal point (e.g., ); results in mmol/L (millimoles of glucose per liter) will always have a decimal point (e.g., ). Check your display to ensure that results are being displayed in the expected units; if they are not, contact your authorized Bayer representative.

Important Important Things to Know 6

Need Help? Call: 1-800-348-8100

1. Have all the materials you will need ready before you begin testing. This includes your Ascensia CONTOUR Meter, the Ascensia CONTOUR Test Strips, and the Ascensia MICROLET Lancing Device with Ascensia MICROLET Lancets. You may also need Ascensia CONTOUR Control Solution to run a quality control check. 2. Read your user guide and all instructional materials provided in your meter kit before testing. 3. Let the meter and test strips adjust to the temperature of the location where you are testing. Whenever the meter is moved from one location to another, allow 20 minutes for the meter to adjust to the temperature of that new location before performing a blood glucose test. The products have been designed to give accurate results at temperatures between 41F and 113F. 4. It is important not to use the test strips or control solution if the expiration date printed on the bottle label and carton has passed or it has been six months (180 days) since you rst opened the bottle. It will help to write the six month discard date on the label in the area provided when you rst open the test strips or control solution. 5. Wash your hands thoroughly with warm soapy water and dry them well. Potential Biohazard Healthcare professionals or persons using this system on multiple patients should follow the infection control procedure approved by their facility. All products or objects which come in contact with human blood, even after cleaning, should be handled as if capable of transmitting viral diseases.2www.BayerDiabetes.com

Before You Begin 7

Important

Before You Begin

Getting Ready to Test: Read the Ascensia M ICROLET Lancing Device insert for complete instructions. Remove the endcap from the Ascensia M ICROLET Lancing Device.

Testing Getting Ready to Test 8

Rotate (do not remove) the protective cap on a lancet turn.

Insert the lancet firmly until it comes to a full stop. This will cock the device. NOTE: You can also pull and release the Cocking End.

Twist off the lancet cap. Be sure to save it for disposing of the used lancet.

Need Help? Call: 1-800-348-8100

Replace the device endcap. Use the gray endcap for ngertip testing. Use the clear endcap for alternative site (forearm or palm) testing. Remove a test strip from the bottle. Tightly close the bottle lid immediately after you have removed the test strip. NOTE: Check the expiration and discard dates. Make sure the test strip does not appear torn or damaged. Hold the test strip with the gray end facing up. Insert the gray end into the test strip port on the meter. No coding needed!

The meter will turn on. A test strip with a ashing blood drop will appear letting you know the meter is ready to test.


Getting Ready to Test 9

Testing

Getting the Blood Drop: Fingertip Testing Use the gray endcap! The depth of the puncture depends upon the adjustable endcap setting you choose and the amount of pressure applied to the puncture site. You should determine which combination works best. Press the gray endcap firmly against the puncture site and press the blue release button.

Shallow Puncture

Deep Puncture

Testing Getting the Blood Drop 10

Wait a few seconds. Stroke your hand and finger towards the puncture site to form a drop of blood. Do not squeeze around the puncture site (milking). Test immediately after you have formed a blood drop (see page 12). IMPORTANT: Fingertip Testing Should Be Done: If you think your blood glucose is low (hypoglycemia). When blood glucose is changing rapidly (after a meal, insulin dose or exercise). If you have hypoglycemic unawareness (lack of symptoms). If you get alternative site blood glucose results that do not agree with how you feel. If you will be driving a car or operating machinery.Need Help? Call: 1-800-348-8100

Alternative Site Testing Use the clear endcap! Do only when it is more than two hours after a meal, diabetes medication, or exercise. Select a puncture site on forearm or palm. Avoid veins, hair, moles, bone and tendon. For palm testing, it is not necessary to rub the skin or pump the device. For forearm testing only, rub testing area vigorously until it feels warm to increase blood flow. Press the clear endcap rmly against the puncture site and then press the blue release button. Keep the device in Press the clear endcap constant contact rmly against the puncwith the skin ture site and then press and pump (apply and release the blue release button. pressure) up and down 23 times without lifting device away from skin. Maintain steady pressure Suggested until the blood drop reachdrop size es the suggested size. Lift device away from the skin without smearing the blood. Do not test blood sample if you get: Smeared blood Clotted blood Runny blood Clear uid mixed with the blood.www.BayerDiabetes.com

Getting the Blood Drop 11

Testing

Testing Your Blood:

Immediately touch the tipof the test strip to the drop of blood. The blood is pulled into the test strip through the tip. Do not press the tip against the skin or place the blood on top of the test strip. Alternative Site Testing

Testing Testing Your Blood 12Forearm

Palm Hold the tip of the test strip in the blood drop until the meter beeps. After the beep, you will see the meter countdown the ve seconds until the test is complete and your result is displayed.

Need Help? Call: 1-800-348-8100

Your test result will automatically be stored in the meter memory. You can set your meter to use special marker options (see pages 2124). Expected Values: Blood glucose values will vary depending on food intake, medication dosages, health, stress or exercise. Consult your healthcare professional for the target value that is appropriate for you. Standard medical practice goals for a typical non-pregnant individual with diabetes are:3 Before a meal glucose: 90 to 130 mg/dL 2 hours after a meal: less than 180 mg/dL CAUTION If your test result is below 50 mg/dL, above 250 mg/dL, or you see LO or HI on the meter display, call your physician or healthcare professional immediately. Do not change your medication based on Ascensia CONTOUR blood glucose results without the advice of your physician or healthcare professional. To turn your meter off, simply remove the test strip. Carefully dispose of the used test strip.


Testing Your Blood 13

Testing

To remove the used lancet: Place the protective cap on a at surface with the Bayer logo facing down. Remove the endcap. (Do not use the same endcap on another person.) With the used lancet still in the lancing device, push the lancet needle completely into the middle of the exposed side of the cap. This will cock the device. Push the blue release button to expose the lancet. Grasp the lancet body and pull it straight out of the device. Do not reuse lancets, they are for single use only. Dispose of the used lancet carefully to prevent injury or contamination to others.

Testing Testing Your Blood 14

Need Help? Call: 1-800-348-8100

Error Codes and Symbols: If you do not resolve the problem, contact Bayer Customer Service at 1-800-348-8100.WHAT YOU SEE (will remain on the display) WHAT IT MEANS Low batteries. WHAT YOU SHOULD DO Replace the batteries as soon as possible. Replace the batteries.

(will ash for 10 Dead batteries. seconds then the meter will turn off) E1 Temperature out of range.

E2

The test strip has not lled enough for an accurate test. The meter is sensing a used test strip.

Remove the test strip and retest using a new test strip. Remove the test strip and retest using a new test strip. Wait until you see the ashing blood drop on the display before adding the blood sample. Remove and reinsert the test strip properly (see page 9). Remove the test strip and retest using a new test strip. If you continue to have problems, contact Bayer Customer Service.

E3

E4

Test strip not inserted correctly.

E5 E12 E6 E13 E8 E14 E9

Potential software or hardware issue.


Error Codes and Symbols 15

Help

Move to an area that is within the operating range for the meter: 41F 113F. Let the meter adjust to this temperature for twenty minutes before testing.

If you do not resolve the problem, contact BayerWHAT YOU SEE E7 WHAT IT MEANS Wrong test strip. WHAT YOU SHOULD DO Remove the test strip and retest using Ascensia CONTOUR Test Strip. See set-up instructions (page 21) to set the date and time on your meter. If you continue to have problems, contact Bayer Customer Service. Remove the test strip and retest using a new test strip. Carefully follow testing instructions in your user guide. If you continue to have problems, contact Bayer Customer Service. Wash your hands and the test site. Repeat the test using a new test strip. If your result is still HI, contact your physician or healthcare professional immediately.

E10

Invalid date or time.

E11

Abnormal result.

HelpHI Test result is above 600 mg/dL.


CAUTION: Glucose levels above 250 mg/dL may indicate a potentially serious medical condition.LO Test result is below 10 mg/dL. Repeat the test using a new test strip. If your result is still LO, contact your physician or healthcare professional immediately.

CAUTION: Glucose levels below 50 mg/dL may indicate a potentially serious medical condition.Need Help? Call: 1-800-348-8100

Customer Service at 1-800-348-8100.WHAT YOU SEE Control test result is out-ofrange (too high or too low). WHAT IT MEANS Test strip or control solution is past the expiration date or is past the discard date. Test strip is deteriorated due to heat or exposure to moisture. Control solution is not at room temperature or may not be mixed well. Incorrect control solution was used. Possible meter electronics failure. WHAT YOU SHOULD DO Make sure you are using Ascensia CONTOUR Control Solution. Gently rock the control bottle to ensure the control solution is mixed well. Run another control test. If result is still out-of-range, retest with a new test strip and control solution. If result is still out of range, call Bayer Customer Service. Check all expiration dates and discard dates. Do not use expired testing materials. Compare meter display with the illustration on page 3. If the display is not correct, contact Bayer Customer Service. Contact Bayer Customer Service.

Results are not displayed in expected units of measure (mg/dL or mmol/L).

This may affect the way you see your results.



Some display segments do not appear when the meter initially turns on.

Help

Control Solution Testing: Use Ascensia CONTOUR Control Solutions to practice on the system or to run a check to make sure the meter and the test strips are working properly. Using another control solution could present incorrect results. Remove a test strip from the bottle. Tightly close the bottle lid immediately after you have removed the test strip. NOTE: Check the expiration and discard date. Make sure the test strip does not appear torn or damaged. Hold the test strip with the gray end facing up. Insert the gray end into the test strip port on the meter. The meter will turn on. A test strip with a ashing blood drop will appear letting you know the meter is ready to test.

Help Control Solution Testing 18

Need Help? Call: 1-800-348-8100

Gently rock the control bottle before opening to ensure it is mixed well. Squeeze a small drop of control solution on a clean nonabsorbent surface (such as a piece of wax paper). Do not apply control solution to the test strip directly from the bottle. Immediately touch the tip of the test strip to the drop of control solution. The solution is pulled into the test strip through the tip.

After the beep, you will see the meter countdown five seconds until the test is complete and your control test result is displayed.

The meter will automatically recognize and mark the control result for you. NOTE: The does not indicate the control test result is within the specied range.


Control Solution Testing 19

Help

Hold it in the drop until the meter beeps.

Compare your control test result with the Normal Control Range printed on the test strip bottle label or on the bottom of the test strip box. NOTE: Low and High control range values can be found on the bottom of the test strip box. If your control test result is out-of-range, see the What You Should Do recommendations on page 17. To turn your meter off, simply remove the test strip. The result will automatically be marked and stored in the meter memory. Control results will not be included in your 14 day blood glucose average or in the 7 day total. Carefully dispose of the used test strip.

Help Control Solution Testing 20

Need Help? Call: 1-800-348-8100

Setting the Date, Time, and Sound: You can set your meter to display different options. To get into set-up mode, press and hold M for three seconds. A complete display will briefly appear, then go to a display with the time.

Setting the Time: The number in the hour position will be ashing. Press or until you reach the correct time. Press M to set. The number in the minute position will now ash. Press or until you reach the correct minute. Press M to set. The PM will now ash. Press or to choose AM or PM. Press M to set.


Options 21

Setting the Date, Time, and Sound

Setting the Date: The date will now appear on the display. The year will be ashing. Press or to reach the current year. Press M to set. The month will now ash. Press or to reach the current month. Press M to set. The day will now ash. Press or to set the day. Press M to set. Setting the Sound: The ashing bell symbol will now appear on the display along with the word . This option controls whether you want to hear the beeps during testing. Press or to choose whether to turn the buzzer on or off. (You will hear a beep when you switch to the screen.) Press M to set.

Setting the Date, Time, and Sound Options 22

Need Help? Call: 1-800-348-8100

Setting the 12 or 24 Hour Clock:12H will now ash on the display. Press or to choose the 12H or 24H setting. This option lets you set the meter to display time as a 12 hour setting with AM and PM or as a 24 hour display (military time). Press M to set.

Setting the Month and Day format: m/d will now ash on the display. Press or to choose how you want the date to appear (month/day or day.month). Press M to set.


Options 23

Setting the Date, Time, and Sound

Setting the Markers and Alarm: Markers and Alarm: You will now see three markers displayed on your meter along with the word . Your Ascensia CONTOUR Meter can give you the option of marking your test results. (See pages 2629 to learn how to use these options!) Press or to turn the marker option on or off. Press M to set. You have now completed the set-up of your meter! The nal display will remain on for 3 seconds showing all the options you have chosen. If you ever want to change the options you have chosen, simply go back to page 21 and follow the set-up instructions.

Setting the Markers and Alarm Options 24

Need Help? Call: 1-800-348-8100

Using the Markers and Alarm: If you have set your meter with the marker option on (see pages 2124), your meter will display three markers next to your blood glucose test result.

Pre-meal = Marks a test result that was taken before a meal. Post-meal = Marks a test result that was taken after a meal. Logbook = Marks any result as being unique or different in some way and for which you may want to make notes in your Clinilog. Seeing a result with this symbol next to it in the memory will help remind you that there is more information recorded about this test result.


Options 25

Using the Markers and Alarm

If you do not want to mark the test result: Press M or remove the used test strip to automatically save the test result in the meter memory. OR Press or until all three markers disappear from the display. Press M and remove the used test strip. Dispose of the used test strip and lancet properly to prevent injury or contamination to others. If you want to mark the test result: Press or to move to the marker you want to set. You will know when you have chosen a marker when you see the box around it ashing on the display. Press M to set. If you mark a result with the , the will appear with a box ashing around it. This allows you to set an alarm that will go off in 2 hours, to remind you to run a post-meal test. If you want to set the alarm, press M. If you do not want to set the alarm, press or . The will disappear showing an empty ashing box. Press M to set.

Using the Markers and Alarm Options 26

Need Help? Call: 1-800-348-8100

The Alarm: When the alarm sounds, the meter will automatically turn on, the alarm will sound 20 times, and the display will show the pre-meal test result you marked when you set the alarm. Pressing any button will silence the alarm. You can now run another test by placing a test strip in the test strip port and following the testing instructions (page 8). When you have completed this test and the result is shown on the display, you may want to mark this test with the to identify this test result as your post-meal result. If you do not want to run another test immediately after the alarm sounds, press any button to turn your meter off. The meter will only set one alarm. It will remember the last alarm set. Any previous alarm setting will be lost. For example: An alarm has been set. You decide to retest before that alarm goes off. If you mark the new test result with a pre-meal marker and set a new alarm , the old alarm setting will be ignored and only the new setting will sound in 2 hours.


Options 27


To Cancel an Alarm: Press M to enter the meter memory. The 14 day average will appear along with the .

Using the Markers and Alarm Options 28

Press M again and a box will appear and flash around the .

TO MARK RESULTS

YOU WILL SEE

TO SET

Pre-Meal Press or (ON)

Press M

Alarm Press or (ON)

Press M

Post-Meal Press or (ON)

Press M

Logbook Press or (ON)

Press M

Need Help? Call: 1-800-348-8100

Press or . The will now indicate the alarm has been turned off.

YOU WILL SEE

WHAT IT MEANS

Result is marked as a pre-meal test. You can now set an alarm. Alarm is set to go off in 2 hours to remind you to run a post-meal test. Result is marked as a post-meal test.

Result is marked in memory as unique. You should note this in your Clinilog.


Options 29


Press M to set.

Using the Memory: With the meter off, press the M button on the meter to view stored test results. The 14 day average will appear on the display with the average for test results taken over the last 14 days. If you have set an alarm that has not sounded yet, you will also see a symbol. Number of results: The number of results included in the average is shown at the top of the display. Your control results are not included in this 14 day average. Press to view the 7 day total. 7 day total: Your meter will display the total number of results taken during the last seven days.

Viewing Stored Results Options 30

High and low results: At the top of the display you will see the number of high results (above 180 mg/dL) and low results (below 72 mg/dL) during that seven day period.

Need Help? Call: 1-800-348-8100

Press to review previous results. Previous results: Results will be shown starting with the most recent. Each result will show the date and time the test was taken as well as any symbols you chose to mark the test result. You can press or to scroll forward or backward through the results. You can press and release the button to view stored results one at a time or you can hold it to move through results continuously. When appears on the display, you have viewed all of the results in the memory. The meter will hold 480 results in the memory. When the maximum is reached, the oldest test result will be removed as a new test is completed and saved to the memory. Press M to turn the meter off, or it will automatically turn off after three minutes.


Options 31

Viewing Stored Results

Changing the Batteries: Batteries should be replaced when the meter continually displays or the meter briey shows and then turns off (See Error Codes and Symbols, page 15). Press rmly on the battery cover and slide in the direction of the arrow. NOTE: If you do not put the new batteries in the meter within ve minutes of taking the old ones out, you may need to reset the date and time. Your other meter settings and stored results will be saved. Remove the old batteries by pressing the top of the battery which will raise the bottom of the battery up.

Changing the Batteries Extras 32

Place new batteries under the prongs and into the battery compartment with the + side up.

Need Help? Call: 1-800-348-8100

Slide the battery cover back into place, lining up with the open slots, and close rmly.

WARNING: Keep batteries away from children.

Lithium batteries are poisonous. If swallowed, immediately contact your physician or poison control center. Discard batteries according to your local environmental regulations. Caring for the System Store meter in the carrying case provided whenever possible.

Handle the meter carefully to avoid damaging the electronics or causing other malfunctions. Avoid exposing meter and test strip to excessive humidity, heat, cold, dust, or dirt. The exterior of the meter can be cleaned using a moist (not wet) lint-free tissue with a mild detergent or disinfectant solution, such as 1 part bleach mixed with 9 parts water. Wipe dry with lint-free tissue after cleaning.CAUTION: Do not allow solution to run down into

the test strip port or around the buttons. Doing so may cause a malfunction.www.BayerDiabetes.com

33

Extras

Caring for the System

Wash hands and dry thoroughly before handling to keep the meter and test strips free of oils and other contaminants.

Transferring Results to a Computer: You can transfer test results from the Ascensia CONTOUR Meter to a computer, where they can be summarized in a report with graphs and tables. To make use of this feature, you need Bayer diabetes management software and a Bayer data cable.

Transferring Results to a Computer Extras

IMPORTANT: The Ascensia CONTOUR Meter has not been tested or certified by Bayer for use with any software other than the Bayer diabetes management software. Bayer is not responsible for any erroneous results from the use of other software.For more information, call our Customer Service Department (1-800-348-8100), or visit our website at www.BayerDiabetes.com.

34

Need Help? Call: 1-800-348-8100

Technical Information: Accuracy: The accuracy of the Ascensia CONTOUR Blood Glucose Monitoring System has been assessed in a correlation study conducted by healthcare professionals. In this study, 108 fresh capillary blood specimens were tested with the Ascensia CONTOUR Blood Glucose Monitoring System by 108 untrained people with diabetes using three test strip lots. The reference measurement was done on the YSI Glucose Analyzer. Ascensia CONTOUR data compare well with the results from the YSI method. Regression Statistics (Plasma/Serum Reference): plasma reference glucose range: 75 to 397 mg/dLLot 1 2 3 y= 1.02x 0.12 mg/dL 1.03x 4.34 mg/dL 0.95x 0.41 mg/dL Correlation Coefcient (r) 0.972 0.963 0.974

Precision: A study was conducted with the Ascensia CONTOUR Blood Glucose Monitoring System with ve heparinized whole blood specimens with glucose levels from 40 to 325 mg/dL. Multiple replicates (n=100) were tested using multiple Ascensia CONTOUR Blood Glucose Meters and one lot of Ascensia CONTOUR Blood Glucose Test Strips. The following precision results were obtained: Plasma/Serum:Mean 38 mg/dL 101 mg/dL 118 mg/dL 205 mg/dL 326 mg/dL SD 1.9 mg/dL 5.1 mg/dL 4.4 mg/dL 6.8 mg/dL 11.7 mg/dL Coefcient of variation 4.8% 5.1% 3.7% 3.3% 3.6%


35

Extras

Technical Information

Specications: Test Sample: Whole blood Test Result: Referenced to plasma/serum glucose Sample Volume: 0.6 L Measuring Range: 10600 mg/dL Measuring Time: 5 seconds Memory Feature: Stores most recent 480 test results Battery Type: Two 3-volt lithium batteries (DL2032 or CR2032) Battery Life: Approximately 1000 tests (1 yr. average use) Operating Temperature Range: 41113F Humidity: 10 93% RH

Specications Extras

Dimensions: 77 mm (H) x 57 mm (W) x 19 mm (T) Weight: 1.7 oz. (47.5 grams) Alarm: Beeps whenever a test strip is inserted into or removed from the meter, when the test strip is lled with blood or control solution, and when a test result appears in the display. Two beeps will sound for an error. Twenty beeps will sound when a programmed alarm goes off.

36

Need Help? Call: 1-800-348-8100

Manufacturers Warranty: Bayer HealthCare warrants to the original purchaser that this instrument will be free from defects in materials and workmanship for 5 years from the date of original purchase (except as noted below). During the stated 5-year period, Bayer HealthCare shall, at no charge, replace a unit found to be defective with an equivalent or current version of the owners model. Limitations of Warranty: This warranty is subject to the following exceptions and limitations: 1. A 90-day warranty only will be extended for consumable parts and/or accessories. 2. This warranty is limited to replacement due to defects in parts or workmanship. Bayer HealthCare shall not be required to replace any units which malfunction or are damaged due to abuse, accidents, alteration, misuse, neglect, maintenance by someone other than Bayer HealthCare, or failure to operate the instrument in accordance with instructions. Further, Bayer HealthCare assumes no liability for malfunction or damage to Bayer HealthCare instruments caused by the use of reagents other than reagents (i.e., Ascensia CONTOUR Test Strips) manufactured or recommended by Bayer HealthCare. 3. Bayer HealthCare reserves the right to make changes in design of this instrument without obligation to incorporate such changes into previously manufactured instruments.


37

Extras

Warranty

4. Bayer HealthCare has no knowledge of the performance of the Ascensia CONTOUR Blood Glucose Meter when used with any test strips other than Ascensia CONTOUR Test Strips, and therefore makes no warranty of the performance of the Ascensia CONTOUR Meter when used with any test strips other than Ascensia CONTOUR Test Strips or when the Ascensia CONTOUR Test Strip is altered or modied in any manner. BAYER HEALTHCARE MAKES NO OTHER EXPRESS WARRANTY FOR THIS PRODUCT. THE OPTION OF REPLACEMENT, DESCRIBED ABOVE, IS BAYER HEALTHCARES ONLY OBLIGATION UNDER THIS WARRANTY. IN NO EVENT SHALL BAYER BE LIABLE FOR INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES, EVEN IF BAYER HEALTHCARE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you. This warranty gives you specic legal rights and you may also have other rights which vary from state to state. For Warranty Service: Purchaser must contact the Customer Service Department of Bayer HealthCare, by calling toll free 1-800-348-8100, for assistance and/or instructions for obtaining service of this instrument.

Warranty Extras

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Need Help? Call: 1-800-348-8100

Service Information: If you have a problem and none of the problem solving steps in the user guide help, call Bayer Customer Service. In the U.S.A., call toll free: 1-800-348-8100 (7 days a week/ 24 hours a day). We have trained specialists to help you. Important: Speak to a Bayer HealthCare Representative before returning your meter for any reason. He/she will give you the information needed to get your problem handled correctly and efciently. Have your Ascensia CONTOUR Blood Glucose Meter and Ascensia CONTOUR Test Strips available when you phone. It would also be helpful to have a bottle of Ascensia CONTOUR Control Solution nearby.


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Extras

Service and Supplies

Supplies: When calling or writing for supplies be sure to include the number with the name of the replacement part or accessory item.

Replacement Parts Part Number* 40030030 Item Two 3-volt Lithium Batteries DL2032 or CR2032 (Free Batteries For Life program. Call 1-800-348-8100.) Ascensia CONTOUR User Guide Bayer Data Cable

99B71519 40453276

These parts are available in the United States from:

Service and Supplies Extras

Bayer HealthCare LLC Customer Service Department Order Entry P. O. Box 2004 Mishawaka, Indiana 46546 or call 1-800-348-8100 to order * Part numbers are subject to change without noticeREFERENCES 1 American Diabetes Association, www.diabetes.org Protection of Laboratory Workers from Occupationally Acquired Infections; Approved GuidelineThird Edition. Clinical and Laboratory Standards Institute (CLSI), document M29-A3, (ISBN 1-56238-567-4). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2005.2

American Diabetes Association: Standards of Medical Care in Diabetes (Position Statement). Diabetes Care 29 (Suppl. 1):S10, 2006.3

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Need Help? Call: 1-800-348-8100

Bayer HealthCare LLC Mishawaka, IN 46544 www.BayerDiabetes.com

Bayer, the Bayer Cross, Ascensia, CONTOUR, MICROFILL and MICROLET are trademarks of Bayer. 2006 Bayer HealthCare LLC Made and Printed in U.S.A.

99B71519

Rev. 9/06

Contour Userguide

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Transcript of Contour Userguide